An investigation into the effects of exercise on walking economy in individuals with osteoarthritis of the hip: A randomized clinical trial

doi:10.21203/rs.3.rs-4843440/v1

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Study protocol

An investigation into the effects of exercise on walking economy in individuals with osteoarthritis of the hip: A randomized clinical trial

https://doi.org/10.21203/rs.3.rs-4843440/v1

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Background

Hip joint osteoarthritis (OA) is a chronic condition that can significantly affect the energetic cost of walking. Exercise is a high-value method for the management and maintenance of function in people with hip joint OA. Walking economy is a measure of the energetic cost of steady-state walking and is associated with declines in physical activity. Previous research has highlighted the ability of exercise programs focusing on improving gait symmetry and reducing step-to-step variability to improve walking economy in older adults. It is unknown if walking economy can be influenced by neuromuscular exercise in those with hip joint OA. Therefore, this study aims to investigate the effects of a neuromuscular exercise program on walking economy in adults with hip joint OA.

Methods

Fifty individuals (25 per group) with hip joint OA will be recruited from the community. Following a baseline assessment, they will be randomly allocated to either 1) an exercise intervention or 2) a control group continuing usual care. The intervention group will undergo a 12-week neuromuscular exercise program focused on improving gait symmetry and reducing step-to-step variability in a group exercise setting. The primary outcome is walking economy at standard and preferred walking speeds. Secondary outcomes include spatiotemporal gait measures (step frequency, length, and width as well as stance and swing duration) and lower limb strength (handheld dynamometer, isometric mid-thigh pull, and wall sit test). Additional measures include self-reported pain, hip function, and physical activity, and body mass index (BMI).

Discussion

The findings from this study will assist practitioners in the prescription of exercises for individuals with hip joint OA. Specifically, we will determine whether a 12-week neuromuscular exercise program can improve walking economy and the likely mechanisms.

Trial registration

Australian New Zealand Clinical Trials Registry, registration number ACTRN12624000411549. Registered 4th April 2024.

Exercise

Gait

Hip Osteoarthritis

Walking economy

Osteoarthritis (OA) is one of the most common musculoskeletal conditions and is ranked in the top 10 leading contributors to disability (1, 2). Hip joint OA is estimated to affect one in four adults over their lifetime (3). There is no cure for hip joint OA, but current treatment strategies, such as exercise programs, focus on maintaining or improving function and pain management (1) and delay or defer the need for joint replacement surgery (4). In addition, maintaining or increasing physical activity is accepted as a valid, cost-effective treatment through all stages of the disease progression (5, 6).

Physical inactivity is an often-underappreciated cause of many chronic conditions, including osteoarthritis (7). Therefore, exercise is not only a means of managing the condition but also part of the prevention strategy. Assisting individuals with osteoarthritis to become more physically active is crucial, as the majority do not meet the activity guidelines (8). In addition, two-thirds of individuals with hip joint OA have coexisting chronic conditions, including cardiovascular and pulmonary diseases, diabetes, and depression (9). Typically, these individuals also report worse pain intensity and a reduction in physical function compared to those without comorbidities (10).

Walking economy is the metabolic cost of walking at a steady speed (11). The primary drivers of this energy expenditure are the muscles that control locomotion (12). These muscles generate forces to perform mechanical work, support body weight, laterally stabilize the body and swing the leg forward (13). Walking economy decreases progressively with age (14). Older adults can expend double or even triple the physiological cost of gait in young adults (15). These increases in energy demands arise due to a distal to proximal transference of muscle activation (16), increased co-contraction of agonist-antagonist lower limb muscles in an attempt to improve stability (17) and inconsistencies in spatio-temporal variables such as step length, swing phase and step frequency (15). This additional energy cost can result in decreased physical activity (18).

Gait changes commonly seen in hip joint OA (19) have been shown to reduce walking economy in older populations (20). A key objective of exercise programming for this group is to improve sensorimotor control and potentially improve gait economy via improvements in symmetry (21). Exercise programming, focused on improving gait symmetry and reducing step-to-step variability in healthy older adults, has demonstrated that improving these factors generates significant increases in walking economy (22–24); however, this has yet to be tested in a group with hip joint OA.

Therefore, the primary aim of this study is to test the hypothesis that 12 weeks of neuromuscular exercise, focused on improving symmetry and reducing variability, will increase walking economy in individuals with hip joint OA. Secondary objectives include investigating changes in muscle strength and spatiotemporal gait variables to explore the relationship between these factors and walking economy.

Trial design

This study is a single-blinded, randomized controlled clinical trial that will take place in a YMCA in the Greater Chicago area, Illinois, USA, and a university gymnasium in the Chilliwack area, British Columbia, Canada. The Auckland University of Technology Ethics Committee (AUTEC) approved the study (23/252). Any changes to the protocol will be communicated to AUTEC for review. All participants will provide written informed consent which will be collected by BH. Due to the expected low risk of harm, there is no planned interim analysis. Exercise is a low-risk management tool commonly prescribed for individuals with hip joint OA and is included in all leading international best-practice guidelines. The protocol is described according to the Standard Protocol Items: Recommendations for Intervention Trials (SPIRIT) statement (25). The trial was prospectively registered in the Australian New Zealand Clinical Trials Registry, registration number ACTRN12624000411549.

Participants and Recruitment

We will advertise the study via printed advertisements in general practitioners' clinics, orthopedic surgeons and physical therapists in the Greater Chicago area, Illinois, USA and the Chilliwack area, BC, Canada, and on social media. We plan to recruit 50 participants between August 1st 2024 and June 30th 2025, with physician-diagnosed hip joint OA or a clinical presentation meeting the American College of Rheumatology criteria for hip joint OA (26). The inclusion / exclusion criteria are described in Table 1.

Table 1

Inclusion/Exclusion Criteria
Inclusion Criteria
Are aged ≥ 50 years;
Have a physician diagnosis of hip joint OA OR
Have hip pain (groin, posterior hip) AND
Have reduced internal rotation ≤ 15˚ AND
Pain on internal rotation AND
Morning stiffness of the hip ≤ 60 minutes
Exclusion Criteria
1. Have other musculoskeletal lower limb or back conditions requiring assessment or treatment in the last 6 months
2. Have a history of hip trauma or surgery on either the affected or unaffected side
3. Have used corticosteroids (oral or intra-articular) in the past 3 months
4. Have a neurological impairment or condition affecting lower limb function
5. Routinely use gait aids
6. Have uncontrolled hypertension or morbid obesity (BMI > 40)
7. Have a systemic inflammatory disease (e.g., rheumatoid arthritis)
8. Have a chronic respiratory disease or cardiac conditions that will restrict the assessment of walking economy
9. Are unable to write, read or comprehend English
10. Have conditions preventing safe participation in physical activity as determined by the Physical Activity Readiness Questionnaire (PAR-Q) (27)
11. Have conditions or factors affecting their ability to take part in the exercise intervention, e.g. unavailable for a 12-week intervention period
12. Have known knee joint pathology that may impact the ability to perform the intervention or reduced knee range of motion (< 90° flexion)

Sample Size Calculations

A sample size calculation was performed via G*Power (28) using data from an intervention investigating the effects of two, 12-week exercise programs on walking economy in older adults (24). The input data for the sample size calculation were statistical power, 95%; 5% significance level; standard deviations: post-intervention, 0.06 (group 1) and 0.10 (group 2); means: post-intervention 0.21 (group 1) and 0.35 (group 2). This study implemented a Student’s t-test. Using the above inputs, an estimated sample size of 38 individuals will be needed for the intervention (19 in each group). To accommodate a potential dropout rate of 20% over the 12 weeks, we will aim to recruit 50 participants.

Procedure

The trial phases are outlined in Fig. 1. Participants will initially be screened over the phone by the principal researcher. At this time, a verbal description of the project will be provided to ensure participants fully understand the trial. If a physician’s diagnosis of hip joint OA has been made, a Physical Activity Readiness Questionnaire (PAR-Q) survey (29) will be conducted over the phone. Once complete, an information sheet and consent form (see Additional File 1 and 2) will be sent online or by mail if no exclusion criteria exist. For those with a history of hip pain without a physician diagnosis, an in-person range of motion assessment will be undertaken to determine suitability (26). Those with appropriate symptoms and movement restrictions will receive the PAR-Q survey, an information sheet and a consent form.

Randomization and allocation concealment

Following baseline assessments, participants will be randomized to either the exercise intervention or control group using block randomization stratified by sex, age and exercise history. An independent statistician will perform randomization and inform a study administrator, who will then notify the participants of their group allocation. The study administrator will not be involved in assessment or data collection. Each participant will receive a unique study identification code. The principal researcher, who will conduct all assessments, will be blind to group allocation. Statistical analysis will be performed blinded. Participants will be aware of the purpose of the study and whether they are allocated to the exercise or control group.

Interventions

Neuromuscular exercise program

The intervention has been described based on the Template for Intervention Description and Replication (TIDIeR) checklist (30). The intervention will use a neuromuscular exercise program designed to improve walking economy. Participants assigned to the exercise intervention will be asked to complete a minimum of two group exercise classes per week for 12 weeks at either the participating YMCA in the Greater Chicago area, Illinois or the gym in the School of Kinesiology at the University of Fraser Valley, Chilliwack, British Columbia. Participants will also be provided with access to pre-recorded classes to perform at home if they are unable to complete the prescribed number of live workouts. The 45-minute classes will be led by qualified group exercise instructors trained in the program's delivery by the principal researcher. The classes will be open to the public. The exercise sessions will consist of flexibility, strength and coordination exercises based on an adaptation of the NEMEX program for a group exercise environment (31). This program has been demonstrated to be a cost-effective means to manage hip joint OA and to improve quality of life (32). The objective of the program is to improve sensorimotor control and strength via functional weight-bearing exercises coupled with floor exercises to isolate targeted hip and core muscles (33). In each class, the instructor will provide options to either increase or decrease the intensity and range of motion of each exercise to cater to varying fitness levels. Each strength exercise has an assisted (chair), body weight, and resisted (plate or exercise tubing) option (see Additional file 3 for a description of the class structure). Participants will complete a weekly training diary to monitor adherence and record any adverse events. No additional changes to usual care and behaviors will be implemented.

Control Group

Participants allocated to the control group will be instructed to continue with their usual care and behaviors. No restrictions will be placed on commencing new management strategies related to hip joint OA during the 12-week intervention. Individuals in the control group in the greater Chicago area will be offered the opportunity to attend the exercise classes for 12 weeks following the completion of the trial. Control group participants in Chilliwack, BC, will be provided with digital copies of the classes at the end of the trial to enable them to do the classes at their leisure.

Outcome measures

Table 2 summarizes the outcome measures.

Primary outcome

Walking economy

Walking economy will be measured at baseline and 12 weeks using the protocol adapted from Richardson et al. (34). Participants unfamiliar with treadmill use will be invited to attend an acclimatization session on a separate occasion, walking for five minutes at 0.72 m/s and their usual walking speed for at least 10 minutes (35). To assess preferred walking speed, participants will walk between two markers placed six meters apart with a three-meter acceleration and deceleration zone at each end. They will be instructed to walk at a comfortable pace and repeat the test until they feel that they have achieved a speed that is representative of their preferred walking speed. This test has been shown to be reliable (36) and well-tolerated in groups with hip pathology (37). After a 5-minute rest period, we will collect standing VO₂ (VO2 Master Health Sensors Inc, Canada) 5 minutes. Participants will then walk at 0.72 m/s for 5 minutes on the treadmill. This speed has been shown to be manageable without being uncomfortably slow (34). They will then walk at their preferred walking speed as measured in the overground test for a further 5 minutes. Oxygen consumption for standing and the two walking speeds will be averaged for the last two minutes of the tests or for two minutes once a steady state of oxygen consumption is observed after a minimum of three minutes. Walking economy will be calculated for each speed as average oxygen consumption during walking minus standing, normalized for walking distance and body mass.

Secondary outcomes

Hip Strength

Bilateral hip muscle strength of the internal and external rotators, flexors, extensors and abductors will be assessed at baseline and 12 weeks using a hand-held dynamometer (38, 39, 40). The treadmill walking tests for economy will act as a warm-up. Marks will be placed 4 cm proximal to the inferior pole of the medial and lateral malleoli, 5 cm proximal to the knee joint line and 5 cm proximal to the superior patella border to designate dynamometer placement. The patient will sit or lie on a treatment table depending on the muscle being tested. When seated they will be instructed to stabilize themselves by holding onto the edge of the table. A submaximal test will be used for familiarization, followed by three, three second maximal tests with resistance applied in a fixed position via a dynamometer (Activforce 2, 66fit New Zealand). Participants will be informed that they can stop at any time due to discomfort. The following order will be used for testing: external rotators, internal rotators, and flexors with the participant seated, hips and knees flexed to 90 degrees. The abductors will be tested during side lying, hip abducted 15 degrees. Hip extension strength will be assessed in prone, hip neutral, knee flexed to 90 degrees. The dynamometer will be placed perpendicular to the direction of force. The highest output in kilograms of the three tests will be recorded.

Lower Limb Strength

A dynamometer attached to a lifting platform will measure the isometric strength of a mid-thigh pull at baseline and 12 weeks. The knees will be flexed at 145 degrees and the hips at 150 degrees, with the feet hip-width apart. A bar will be held at mid-thigh level, and participants will be instructed to “drive your feet into the floor and pull up on the bar as hard as possible.” Three trials will be completed, and the maximum value will be recorded (41).

Lower Limb Strength Endurance

A wall-sit strength endurance test will be conducted at baseline and 12 weeks. Subjects will be instructed to stand upright with their back against the wall, feet parallel and shoulder-width apart, and hands by their sides. A goniometer will be aligned with the lateral condyle of the right femur, with the upper arm extending along the femur in line with the greater trochanter and the lower arm extending along the fibula in line with the lateral malleolus. Subjects will be instructed to lower their back down the wall until a knee joint angle of 100 degrees knee flexion is achieved or to a degree of flexion where they are comfortable. All subjects will be asked to maintain this position until a point of failure (42).

Spatiotemporal Gait Measures

Spatiotemporal gait measures will be conducted at baseline and 12 weeks via the OpenCAP (Stanford University, USA) video capture system (43). Data will be collected via two smart phone cameras placed at the rear of the treadmill during the preferred walking speed phase of the walking economy assessment. Phones will be placed at approximately 45 degrees relative to the treadmill. Data files collected during the video analysis will be processed via a pre coded template on Matlab (MathWorks Inc) to obtain values of the following gait variables: step frequency (steps/minute), step length (meters), step width (meters), stride duration (seconds), stance duration (seconds), swing duration (seconds), and double support duration (seconds).

Five Repetition Sit to Stand Test

Participants will complete a five-repetition sit-to-stand test at baseline and on completion of the 12-week intervention period (44). Participants will sit on a chair with arms across the chest and instructed to move from sitting to standing five times as quickly as possible while maintaining control. The time to complete the test will be recorded. Additionally, we will capture video data with two smart phone cameras positioned at 45-degree angles facing the chair. Motion analysis will be conducted via OpenCAP to determine maximum trunk flexion utilized during the test (43).

Other Measures

Exercise Adherence

A training diary will record the number of completed online and group exercise classes weekly. This diary will also capture any additional structured (planned) exercise sessions completed each week. The control group will record any planned, structured exercise sessions over the 12-week period.

Table 2

Outcome Measures
	Data collection Instrument	Time Points
		Baseline	12 weeks
Descriptive Data
Age, sex, socioeconomic status		√
Body mass index		√	√
Hip symptoms	HOOS Survey	√	√
Physical activity	CHAMPS Survey	√	√
6-month exercise history		√
Physical Activity Readiness	PAR-Q Survey	√
Primary Outcomes
Walking economy	VO2 Master	√	√
Secondary Outcomes
Hip strength	Hand-held dynamometer	√	√
Lower limb strength	Mid-thigh pull dynamometer	√	√
Strength endurance	Wall sit test	√	√
Spatio-temporal gait measures	Open-CAP video analysis	√	√
Five repetition sit to stand test	Open-CAP Video Analysis	√	√
Hip Function	HOOS Survey	√	√
Pain	P4 Pain Scale Survey	√	√
Other measures
Adherence	Exercise diary	Weekly
Adverse events	Exercise diary	Weekly

HOOS Hip Osteoarthritis Outcome Score, CHAMPS Community Healthy Activities Model Program for Seniors, PAR-Q Physical Activity Readiness Questionnaire

Data collection and management

Screening information will be stored in REDCap, and consent forms will be stored on a password-protected computer. Data will be backed up to a data cloud system with two-factor security. Any hard copies will be scanned and shredded. Data shared with the wider research team will be anonymized.

Once participants have been deemed eligible (Fig. 1), baseline surveys will be sent online via REDCap or completed in hard copy and entered into REDCap as soon as practically possible. Surveys will include Socioeconomic Status (45), Community Healthy Activities Model Program for Seniors (CHAMPS) (46), Hip Osteoarthritis Outcome Score (HOOS) (47), 6-month exercise history, and P4 Pain Scale (48). The CHAMPS, HOOS, and P4 Pain Scale surveys will be completed again at 12 weeks following the intervention. In addition, an exercise diary will be completed weekly.

All physical assessments will be conducted at baseline and 12 weeks at participating gyms in the greater Chicago area, Illinois, USA and Chilliwack, BC, Canada. Data will be kept on a password-protected computer. Assessment details will be collected electronically via measuring apps, VO2 Master (VO2 Master Health Sensors Inc, BC, Canada), OpenCap (43) and ACTIVFORCE 2 Digital Dynamometer (66fit, New Zealand) and transferred to Microsoft EXCEL. Other assessments (self-selected walking speed, isometric mid-thigh pull, BMI and wall sit test) will be recorded digitally in Microsoft EXCEL and kept on a password-protected computer.

Adverse Events

Participants will be requested to record any adverse events in their training diary and inform the research administrator of any events by phone. If necessary, participation will be discontinued, and a medical assessment arranged. Participants will be asked to provide details on the nature of the adverse event, how long it lasted, and any treatment undertaken. If the event is related to the exercise program, it will be considered a related adverse event. Serious adverse events, including unexpected medical occurrences resulting in death, hospitalization, or significant disability, will be reported to the ethics committee.

Data analysis

All data will be analyzed regardless of protocol adherence. All statistical analysis will be conducted using IBM SPSS (IBM Corp, Armonk, NY) or similar software. Data will be tested for normal distribution using a Shapiro-Wilk test, and descriptive data will be summarized as means, standard deviations, and confidence intervals for each group. Between- and within-group ANOVAs will be calculated using the primary outcome to test the central hypothesis, with an alpha level of p < 0.05. If models are significant, post-hoc analysis (using t-tests, Chi-square or Mann-Whitney tests) will be used to identify where the difference occurred, corrected for multiple comparisons (e.g., Tukey’s test).

The secondary research question will be tested using an explorative analysis of factors that may be associated with changes in walking economy. This analysis will investigate the potential for a predictive model to guide future research investigating exercise management and walking economy in individuals with hip joint OA. The association between changes in walking economy and independent variables that make conceptual sense will be assessed with ElasticNet Regression models (49) using automated parameter selection via k-fold cross-validation. ElasticNet Regression is a data-driven approach that deals with multiple independent variables with a high degree of multicollinearity.

Timeline

Ethical approval

was provided by AUTEC (Auckland University of Technology Ethics Committee) in December 2023. Recruitment will commence in June 2024 and continue through to October 2024. The trial is due for completion in December 2024, when all participants will have completed 12 weeks of the intervention.

Patient and Public Involvement

Trials of the class format and instructor training have been undertaken at three YMCAs in North Carolina, USA, which are not participating in the intervention. Feedback provided by YMCA management, instructors and participants has been incorporated into the class design, instructor training and implementation strategies. This consultation ensures that the delivery of this program in a group exercise setting is scalable and, therefore, accessible to the public. The assessment protocol was trialed on YMCA staff at the assessment facility in the Greater Chicago area. Subsequent modifications were made to minimize participant burden and reduce the potential for hip joint discomfort based on feedback.

Dissemination

Findings of this investigation will be disseminated via publication in peer-reviewed journals and presentations at conferences.

This article outlines the theoretical foundation, rationale, and protocol for a single-blinded randomized controlled clinical trial investigating the effects of a neuromuscular exercise program, focusing on improving gait consistency and symmetry on walking economy in individuals with hip joint OA. Structured, land-based exercise has been designated a core treatment for individuals with hip joint OA (50). A key objective of exercise programming is to increase or maintain physical activity levels, prevent the onset of comorbidities, and prevent or delay the need for arthroplasty. Reduction in walking economy is associated with declines in physical activity; however, the effects of an integrated exercise program on walking economy, while investigated in older populations, have not been explored in individuals with hip joint OA. Findings from this trial will assist clinicians and patients by determining whether neuromuscular exercise can improve walking economy via increased symmetry, reduced step = to-step variability and improvements in strength in individuals with hip joint OA.

Osteoarthritis

SPIRIT

Standard Protocol Items:Recommendations for Intervention Trials

YMCA

Young Men’s Christian Association

PAR-Q

Physical Activity Readiness Questionnaire

TIDIER

Template for Intervention Description and Replication

NEMEX Neuromuscular Exercise Program

HOOS

Hip Osteoarthritis Outcome Score

CHAMPS

Community Healthy Activities Model Program for Seniors

AUTEC

Auckland University of Technology Ethics Committee.

Acknowledgements

We would like to thank the YMCA of Metro Chicago for hosting the classes and Les Mills International for the creation of the classes and approval to use them for the intervention.

Author’s contributions

BH, JG, DR conceived the idea for the study and BH is leading the trial. BH, DR, GH, SGW, JG designed the protocol. BH drafted the manuscript with input from DR, GH, SGW and JG. All authors read and approved the final manuscript.

Funding

Les Mills International Ltd (Auckland, New Zealand) contributed funds for assessment equipment, participant reimbursement and provided the exercise classes. They had no role in the design of the study and will not have any role during its execution, analyses, interpretation of the data or decision to submit results.

Availability of data and materials

The data and analyses used will be available from the corresponding author ([email protected]) on reasonable request once the study is completed.

Ethics approval and consent to participate

Ethical approval has been obtained from the Auckland University of Technology Ethics Committee (AUTEC 23/252). All participants will provide informed consent. Recruitment has not yet commenced.

Consent for publication

Not applicable

Competing interests

BH is a contractor to Les Mills International.

Author Details

¹Physiotherapy, Auckland University of Technology Faculty of Health and Environmental Sciences, Auckland, New Zealand, Active Living and Rehabilitation Aotearoa (ALARA)

² Department of Integrative Physiology, University of Colorado, Boulder, USA

³ School of Kinesiology, University of the Fraser Valley, Chilliwack, BC, Canada

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No competing interests reported.

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An investigation into the effects of exercise on walking economy in individuals with osteoarthritis of the hip: A randomized clinical trial

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Version 1

Abstract

Background

Methods

Discussion

Trial registration

Figures

Background

Methods

Hip Strength

Lower Limb Strength

Lower Limb Strength Endurance

Spatiotemporal Gait Measures

Five Repetition Sit to Stand Test

Exercise Adherence

Data analysis

Discussion

Abbreviations

Declarations

References

Additional Declarations

Supplementary Files

Status:

Version 1